The current practice necessitates the use of a needle through a self sealing rubber stoppered port in a Y-shaped injection unit. Some examples demonstrating the use of needles at a Y-shaped injection unit are U.S. Pat. Nos. 4,121,585 (Becker, Jr.), issued Oct. 24, 1978, 4,585,435 (Vaillancourt), issued Apr. 29, 1986, and 4,596,557 (Pexa), issued June 24, 1986.
The health risk associated with needle sticks has become of great concern to the medical community. This is evidenced by the recently published article, "Despite Safety Guidelines, Various Devices Still Cause Needle-Stick Injuries," Oncology Nurse Bulletin, (NCM Publishers, Inc.), October 1988, pp. 2 and 8. This article discusses the complacency about needle sticks which causes approximately 300 health care workers to die each year from direct or indirect consequences of occupational acquired hepatitis B, not to mention the number which test positive each year to AIDS testing. The article continues to state that "the second most common cause of needle sticks, and the biggest rate of injury, came from accidents involving intravenous tubing needle assemblies". In these accidents, over one quarter were related to recapping, and this was probably due to the fact that the needle caps were unavailable when intravenous lines were dismantled. The needle sticks occurred when alternative methods, such as introducing needles into drip chambers, intravenous ports or bags, were used for covering the needles.
Thus, needle sticks can occur from recapping of needles, poor needle connections, attempts at removal of a needle by loosening of the needle hub from the tubing, and when the needle is either manually or accidental dislodged from the tubing.
Any injury from a used needle is potential for infection, especially hepatitis B and AIDS. FIG. 2, attached hereto, depicts a conventional infusion port 50 which includes a polyvinylchloride primary infusion tubing 51, tubing 56, Y-shaped injection unit 52, and self sealing rubber stopper 54. Y-shaped injection unit 52 includes a primary infusion port 58 and a secondary infusion port 59. During administration of a secondary medication or other fluid a needle 55 is injected into self sealing rubber stopper 54 located about the opening of secondary infusion port 59. After injection needle 55 is capable of introducing a secondary infusion into Y-shaped injection unit 52.
Needle sticks occur during the injection and withdrawal of needle 55 from stopper 54, and at most anytime when the needle is uncapped, transported or disposed. Since intravenous injections are common place in medical treatment, it is entirely to risky to continue to expose medical personnel to needle sticks which can lead to the contraction of infectious diseases.
The present inventor has developed a unique device which does not require the use of needles to deliver secondary medications to intravenous systems, thereby completely eliminating the threat of contracting infectious diseases when a secondary medication or blood transfusion is administered via an intravenous system.
One device which attempts to eliminate the use of needles during the administration of secondary medications or blood transfusions to the Y-shaped injection unit of an intravenous system is set forth in U.S. Pat. No. 3,994,293 (Ferro), issued Nov. 30, 1,976. The Ferro patent describes an injection assembly which can be used in combination with a feeding means (e.g., a syringe) for feeding, into a transfusional or perfusional liquid, a nourishing solution, a vitamin solution, a medicinal solution, an anticoagulant solution or a like solution, wherein penetration of a hollow piercing member (e.g., a syringe needle) into the injector body is not necessary. The purpose of the device set forth in the Ferro patent is to overcome the disadvantages caused by repeatedly injecting new needles into the injector wall. That is, after repeated injections the injector wall weakens and is no longer adequately sealed.
The Ferro patent makes use of a liquid pressure-actuated elastomeric diaphragm positioned in the tubular branch portion. The diaphragm includes a pre-perforated portion formed having a pressure threshold corresponding to a predetermined pressure of the solution upstream of the diaphragm. The pre-perforated portion is normally impervious to prevent passage of the solution through the tubular branch portion of the tubular conduit portion when the pressure of the solution upstream of the diaphragm is less than the pressure threshold. The pre-perforated portion becomes pervious to allow passage of the solution through the tubular branch portion to the tubular conduit portion when the pressure of the solution upstream of the diaphragm is at least equal to or greater than the pressure threshold. Furthermore, a valve means cooperating with the preperforated portion of the diaphragm only permits unidirectional feeding of the solution in the tubular portion through the pre-perforated portion to the tubular conduit portion, but not vice versa.
One disadvantage of the injector assembly set forth in the Ferro patent is that it causes air in the tubing and does not permit bidirectional movement of the pre-perforated portion of the diaphragm.
Various needleless syringe assemblies have been designed for use in catheter devices, e.g., U.S. Pat. Nos. 4,752,287 (Kurtz et al.), issued June 21, 1988, 4,816,020 (Brownell), issued Mar. 28, 1989, and 4,333,455 (Bodicky), issued June 8, 1982. These devices are concerned with inflation of catheter balloons and not the injection of secondary medicines or solutions into an intravenous system.
The present invention overcomes the aforementioned disadvantages of conventional intravenous injection systems by providing a device which eliminates the use of needles in the administration of secondary medications or other solutions via a Y-shaped injection port. The present invention also completely eliminates the risk of contracting an infectious disease due to needle sticks during the handling of intravenous systems.
The present invention accomplishes the aforementioned advantages by providing a novel two-way valve infusion port which permits administration of secondary medications or other solutions without the injection of a needle and permits bidirectional movement of the valve to avoid backflow of solution or air contamination of the intravenous system.
Additional advantages of the present invention shall become apparent as described below.